Background & Aims

The superiority of anti-TNF-α agents to thiopurines for the prevention of postoperative recurrence of Crohn’s disease (CD) after ileocolonic resection remains controversial. In this meta-analysis of individual participant data (IPD), the effect of both strategies was compared and assessed after risk stratification.

Methods

After a systematic literature search, IPD were requested from randomized controlled trials investigating thiopurines and/or anti-TNF-α agents after ileocolonic resection. Primary outcome was endoscopic recurrence (ER) (Rutgeerts score ≥i2) and secondary outcomes were clinical recurrence (Harvey-Bradshaw Index/Crohn’s Disease Activity Index score) and severe ER (Rutgeerts score ≥i3). A fixed effect network meta-analysis was performed. Subgroup effects were assessed and a prediction model was established using Poisson regression models, including sex, smoking, Montreal classification, CD duration, history of prior resection and previous exposure to anti-TNF-α or thiopurines.

Results

In the meta-analysis of IPD, 645 participants from 6 studies were included. In the total population, a superior effect was demonstrated for anti-TNF-α compared with thiopurine prophylaxis for ER (relative risk [RR], 0.52; 95% confidence interval [CI], 0.33–0.80), clinical recurrence (RR, 0.50; 95% CI, 0.26–0.96), and severe ER (RR, 0.41; 95% CI, 0.21–0.79). No differential subgroup effects were found for ER. In Poisson regression analysis, previous exposure to anti-TNF-α and penetrating disease behavior were associated with ER risk. The advantage of anti-TNF-α agents as compared with thiopurines was observed in low- and high-risk groups.

Conclusions

Anti-TNF-α is superior to thiopurine prophylaxis for the prevention of endoscopic and clinical postoperative CD recurrence after ileocolonic resection. The advantage of anti-TNF-α agents was confirmed in subgroup analysis and after risk stratification.

中文翻译：

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抗 TNF 与硫嘌呤的风险预测和比较疗效，用于预防克罗恩病术后复发：6 项试验的汇总分析

背景与目标

抗 TNF-α 药物在预防回结肠切除术后克罗恩病 (CD) 术后复发方面优于硫嘌呤类药物仍存在争议。在这项对个体参与者数据 (IPD) 的荟萃分析中，在风险分层后比较和评估了两种策略的效果。

方法

在进行系统的文献检索后，IPD 被要求来自调查回结肠切除术后硫嘌呤和/或抗 TNF-α 药物的随机对照试验。主要结果是内镜下复发 (ER)（Rutgeerts 评分≥i2），次要结果是临床复发（Harvey-Bradshaw 指数/克罗恩病活动指数评分）和严重 ER（Rutgeerts 评分≥i3）。进行了固定效应网络荟萃分析。评估亚组效应并使用泊松回归模型建立预测模型，包括性别、吸烟、蒙特利尔分类、CD 持续时间、既往切除史和既往抗 TNF-α 或硫嘌呤暴露史。

结果

在 IPD 的荟萃分析中，包括来自 6 项研究的 645 名参与者。在总人群中，与硫嘌呤相比，抗 TNF-α 药物预防 ER（相对风险 [RR]，0.52；95% 置信区间 [CI]，0.33–0.80）、临床复发（RR，0.50 ；95% CI，0.26–0.96）和严重 ER（RR，0.41；95% CI，0.21–0.79）。没有发现 ER 的差异亚组效应。在泊松回归分析中，先前接触抗 TNF-α 和穿透性疾病行为与 ER 风险相关。在低风险和高风险人群中观察到抗 TNF-α 药物与硫嘌呤相比的优势。

结论

抗 TNF-α 在预防回结肠切除术后内镜和临床术后 CD 复发方面优于硫嘌呤预防。亚组分析和风险分层后证实了抗 TNF-α 药物的优势。